After a transformational start to the millennium, we enter a new decade
that will build on our vision to emerge as a global biopharmaceutical
enterprise that delivers valuable and affordable products and services
to patients, partners and healthcare providers the world over. Our
efforts thus far, have seen us take calculated and deliberate steps to
build a risk balanced portfolio of biopharmaceutical products and
services through a number of valuable research and marketing
partnerships. This judicious growth strategy has enabled us to become
global suppliers of drug substances like statins, immunosuppressants
and insulins. Adopting a portfolio approach for our research pipeline,
we have created high value R&D assets that
we are periodically unlocking through licensing or via market access.
The path ahead is about building Brand Biocon through products that can
make a diff- erence to chronic diseases like diabetes, cancer,
cardiovascular, autoimmune and renal malfunction.
The journey ahead is therefore one of value added transition. From
drug substance to drug product. From Drug Master Files (DMFs) to
Product Dossiers. Over the last decade, Biocon has built signifcant
brand equity across our customer base. The task before us now, is to
extend that brand recognition to our products in the retail market.
In building Brand Biocon, we look beyond the market and aim to deliver
medical education to healthcare pro- fessionals and patients with a
view to create greater awareness of disease management and thereby,
better out-
come. Brand Biocon is committed to making a difference to patients
through affordable drug innovation.
I am very happy to share with you the progress we have made in creating
this brand recognition.
Brand Building through Differentiation and Specialization
We have adopted a well researched business strategy to develop products
that address chronic therapies in select disease segments. We have
identified anchor products to spearhead the launch of our brands into
the Indian market. The first such key product was recombinant human
insulin branded Insugen® that launched our Diabetology division in
2004. Entering at the lowest rung, we have worked our way up the
anti-diabetic value chain to be ranked 12th in our represented market
last fiscal. Insugen® is a leading brand in the country today, rapidly
narrowing the gap with its innovator counterparts.
Our first insulin analog Glargine, branded BASALOG® was introduced into
the market in 2010 and is already the No. 2 brand. We have innovatively
supported this division by a successful patient engagement program,
Winning with Diabetes, and are now creating a medical education forum,
ABIDE. This forum enables doctor-patient interface based on an IT
platform and aims to disseminate medical information and training
modules to diabetics and physicians in remote reaches of the country.
Spurred by the success of our insulins, we entered into an exciting
agreement with Pfizer to address a large and lucra- tive global
biosimilar insulin opportunity.
Biocon has also developed a very strong portfolio around Chronic Kidney
Disease. Our Nephrology division has performed exceedingly well with
its flagship brands TACROGRAF™ (tacrolimus) now occupying the No. 2
position in the market and RENODAPT® (mycophenolate mofetil) the third
largest brand in its category. Impressive branding, high share of noise
in the market and a differentiated safety device have propelled the
success of
our ERYPRO™ group of erythropoietin based therapies for the dialysis
segment.
In Oncology, our brand portfolio has garnered impressive market share.
Anchored by our proprietary, anti- cancer MAb, BIOMAb EGFR® and
supported by our flagship albumin fusion nanoparticle taxane, Abraxane®
and our biosimilar Granulocyte Stimu- lating Factor (GCSF), NUFIL™, the
division is gaining good traction in the market having recorded a
robust YoY growth this fiscal.
The fourth division, Cardiology, launched in 2008 has been propelled by
our flagship brand STATIX® to a ranking of 23 in a highly crowded
market. Q3 2011 saw the launch of PRASACT™ (prasugrel) and TIROZEST™
(tirofiban) to consolidate our interven- tional cardiology portfolio.
Recent introductions like BESTOR® (rosuvastatin) and ACTIBLOK™
(metoprolol) continue to follow a high growth trajectory.
In FY 2011, we added two more divisions, Immunotherapy and Com-
prehensive Care. The Immunotherapy focus in Phase I, is on introducing
molecules for the treatment of
immune-related dermatological disorders, launched with two diff-
erentiated molecules in its armory – TBIS® (tacrolimus) and PICON®
(pimecrolimus), for the treatment of atopic dermatitis and vitiligo.
Both drugs have been well accepted and are performing exceedingly well
in the market.
To cater to the critical care segment, Biocon launched a Comprehensive
Care Division to provide affordable, quality medicines for illness
including nosocomial infections, post-surgical complications, trauma
and medical emergencies. I am proud to declare that within just six
months from launch, this division has gained entry to the countrys
best corporate hospitals with its high quality portfolio of specialty
products.
Research & Development
Biocons R&D has had a successful, decade long track record of
innovation. Our research efforts have generated a pipeline of generic
small molecules, biosimilars and novel biologics with the potential of
unleashing high value growth in a sustained manner over the foreseeable
future.
Our portfolio of generic molecules has enabled us to garner a dominant
position as a supplier of generic APIs viz. statins and
immunosuppressants to US, European and Latin American markets. This, I
am pleased to say, has yielded good financial returns and has allowed
us to forge very strong part- nerships with global generics compa-
nies. One such partner, Mylan, has extended this relationship in 2009,
to a portfolio of biosimilar monoclonal antibodies. In October 2010, we
announced a global commercialization partnership with Pfizer for our
portfolio of recombinant human insulin and insulin analogs. Given the
growing incidence of diabetes the world over, biosimlar insulins offer
a large market opportunity from 2014.
Our novel pipeline is also rapidly advancing into the clinic. The most
advanced programs are IN-105 (oral insulin) and T1h (itolizumab), an
anti-CD6 targeting MAb, both of which have completed a Phase II/III
proof of efficacy clinical studies. Although oral insulin did not meet
its desired primary end-point of HbA1c lowering, this was attributable
to an unexpectedly high placebo effect due to frequent self
blood glucose monitoring. However, all secondary end-points were met,
indicative of proof of action, another program, BVX-20, a humanized
anti- CD20 monoclonal antibody being co-developed with Vaccinex, is
about to enter the clinic. Two more in early stages of development are:
a hybrid peptide with dual pharmacology for type II diabetes being
co-developed with Amylin; and immunoconjugated MAbs which will function
as tumor vaccines, being developed with IatriCa, a start-up which
originated from a discovery made at the Johns Hopkins University. We
expect to initiate discussions for partnering a few of these programs
in the coming fiscal.
Strategic Partnerships
Partnering has always been at the heart of Biocons business philosophy
and we will continue to build value through strategic partnering. We
have sought both research and marketing partner- ships as a way to make
global impact.
Pfizer
The most visible and high profile part- nership that we recently
announced was with the worlds leading pharmaceutical company, Pfizer,
to commercialize
our insulins portfolio. Pfizer will have exclusive and a few
co-exclusive rights to commercialize these products globally, while
Biocon will be respon- sible for the clinical development, manufacture
and supply of these biosimilar insulin products. We firmly believe this
landmark partnership will drive considerable growth in the foreseeable
future.
Optimer
FY 2011 also saw Biocon and Optimer Pharmaceuticals Inc. enter into a
long term supply agreement for the com- mercial manufacturing of the
API, fidaxomicin, Optimers new drug for the treatment of C. diffcile.
I believe, our partnership with Optimer is an emphatic recognition of
Biocons cap- abilities as an R&D partner as well as an acknowledgement
of our global biomanufacturing strength. I am delighted to inform you
that Optimer has just received US FDA approval for this molecule which
positions Biocon as a sole supplier of this drug substance for the
market launch.
Strategic Foreign Direct Investment
World class infrastructure and attractive tax incentives make Malaysia
a compell- ing destination for biotechnology. Investing in Malaysia
provides us with an international location with strategic geographical
proximity to India. Biocon is pleased to be an early mover in this
emerging opportunity and have agreed to invest in establishing a
biomanufacturing facility at Bio-XCell, a custom-built biotechnology
park in Iskandar Malaysia, Johor. This invest- ment is the largest for
the Malaysian biotechnology sector thus far. In the first phase, Biocon
proposes to invest around RM 500 million (approximately USD 161
million) to create an insulin manufacturing facility targeted to be
operational by 2014.
Research Services
Our research services business supported by Syngene and Clinigene,
continues to be a key growth driver, delivering a CAGR of 13%. We are
well positioned to take advantage of the increasing trend in big pharma
to externalize R&D. Additionally, there is a perceptible drift from
fee for service and component services to integrated R&D and
partnered co-development on a risk sharing platform. Between Syngene
and Clinigene, we are uniquely placed to offer end-to-end integrated
services in both small and large molecules.
Our partnership with Bristol-Myers Squibb is a fore runner of this
integrated service model. The customized R&D hub, BBRC, that has been
created at Syngene, is enabling BMS to pursue pipeline development
through a team of over 450 scientists working seamlessly with BMS labs
in the U.S.
Beyond Borders
NeoBiocon
After the successful launch of Abraxane® in the UAE region, this year
NeoBiocon has introduced a range of branded generic products in therapy
areas of cardiology, diabetology and infection management. We are
pleased with the progress of this JV and look forward to greater access
to this high growth region.
AxiCorp
Pursuant to our global insulins part- nership with Pfizer, I would like
to announce that Biocon is divesting its stake in its German
subsidiary, AxiCorp
GmbH, to the existing group of pro- moter shareholders. We believe that
this is in the best interests of the shareholders of both companies.
Axicorp has done an admirable job in sustaining profitability under
difficult external circumstances, triggered by German healthcare
reforms. Biocon wishes AxiCorp´s management and employees the very best
in their future endeavors.
Corporate Social Responsibility
The year gone by saw Biocon Foun- dation being focused on integrating
its health initiatives to maximize their impact and relevance to the
comm- unities it works with. By bringing together the Foundations
programs in preventive healthcare, primary health- care and health
insurance for surgery and other hospital care, we aim to make our
healthcare interventions more effective, sustainable and scalable.
In FY 2011 we concentrated on preventive health, particularly
addressing problems related to the paucity of doctors. Keeping this in
mind, we train community health workers to be peer educators and
helpers who administer our programs, ranging from a unique mobile phone
based cancer screening program, to preventive health education.
Biocon and Biocon Foundation have also assisted the Government of
Karnataka in building hundreds of homes for displaced families in the
Bagalkot district of Karnataka that was severely affected by foods.
Looking Ahead
I strongly believe that what we have achieved so far is the beginning
of a new era of growth. The critical mass
we have built in the domestic formu- lations space gives us the
confidence to pursue a larger and more responsive brand position in the
market. We are now Asias largest biopharma company and the only Asian
company among the top 25 in global biopharma. We are committed to
strengthening our growth trajectory through branded formu- lations, a
strong R&D pipeline, an integrated portfolio of research services and
strategic partnering that provides a global footprint. I would like to
see Brand Biocon build on its core values of quality, affordability,
reliability and innovation. That to me is the true and
enduring test of a successful brand in the global arena.
Once again, I commend Biocons people for their entrepreneurial spirit,
commit- ment, teamwork and integrity. Inspired by the tremendous
possibilities of science, Team Biocon has remained admirably focused on
advancing novel therapies, driving our businesses and supporting
patient health, the world over. I look forward to the year ahead with a
sense of confidence to deliver even greater value to all our
stakeholders.
Yours sincerely,
Kiran Mazumdar-Shaw
May 2011
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